GxP Systems Admin: Regulated Pharma IT & Compliance

Stark Pharma Solutions Inc; Lexington (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

Stark Pharma Solutions Inc in Lexington, MA is hiring a GxP Systems Admin to support regulated manufacturing, laboratory, and automation systems. You will administer systems, manage access, perform maintenance, and ensure data integrity and validation compliance.

You will collaborate with Quality, Manufacturing, IT, Validation, and Engineering to support operations and lead change controls and CAPAs as needed.

Qualifications

• Bachelor's degree in IT, engineering, life sciences, CS, or related field.
• 2+ to 4+ years of experience with GxP-regulated systems in pharma or life sciences.
• Experience supporting manufacturing, laboratory, or automation applications.
• Working knowledge of DCS/SCADA systems (DeltaV, FactoryTalk, Metasys).
• Experience with historian systems (PI) and LabX, Unicorn, Sartocheck, Nova Biomass, ThinManager.
• Strong understanding of data integrity principles (ALCOA+), CSV, and Change Control & CAPA (TrackWise).
• Experience managing user access, system security, troubleshooting, backups.
• Strong troubleshooting, documentation, communication and problem-solving skills.

Responsibilities

• Administer and support GxP-regulated computerized systems across manufacturing, laboratory, and automation environments.
• Manage user accounts, system access, permissions, and security controls.
• Perform system maintenance, monitoring, troubleshooting, backups, and routine health checks.
• Support periodic system reviews, audits, inspections, and compliance activities.
• Maintain system administration records, logs, and documentation.
• Participate in change control, deviation investigations, and CAPA activities.
• Ensure compliance with data integrity principles, CSV requirements, and regulatory standards.
• Collaborate with Quality, Manufacturing, IT, Validation, and Engineering teams to support business operations.

Skills

GxP Systems Administration

Troubleshooting

Documentation

Communication

Regulatory Compliance

Education

Bachelor's degree in IT, Engineering, Life Sciences, CS, or related field

Tools

DeltaV

FactoryTalk

Metasys

PI Historian

LabX

Unicorn

Sartocheck

Nova Biomass

ThinManager

TrackWise

Job description

Stark Pharma Solutions Inc in Lexington, MA is hiring a GxP Systems Admin to support regulated manufacturing, laboratory, and automation systems. You will administer systems, manage access, perform maintenance, and ensure data integrity and validation compliance.

You will collaborate with Quality, Manufacturing, IT, Validation, and Engineering to support operations and lead change controls and CAPAs as needed.